Virtue®

Product information & resources

Product description

Product description

The Coloplast Virtue male sling is a less invasive treatment designed for all ranges of stress urinary incontinence (SUI) in male patients. It combines technologically advanced design, construction, materials and surgical approach. Virtue is the only male sling that utilizes a unique four-arm approach designed to provide confident compression. The four-arm design and strong mesh made of 100% monofilament polypropylene provide bidirectional compression and elevation of the bulbous urethra.

Design

Virtue® is the only male sling that utilizes a four-arm approach to alleviate stress urinary incontinence.

Four arm components contribute to continence (cf. 1, 2)

Elevated and elongated compression of the bulbar urethra

Dependability

Virtue data suggests that it can be successfully used for all ranges of men with stress incontinence.

Patient Satisfaction: 78% of patients are very much or much improved at 6 months (cf. 2)

Delivery

Virtue is easy to use and offers distinct features to help minimize complications.

Suture loops provide easy removal of sling from introducer

Suture knobs provide secure attachment of arms to introducer

Alexis® wound protector/retractor holds the incision site open to allow easy access and maximum visibility to the operative field (cf. 3)

Delineation

Virtue can be effectively evaluated intra-operatively.

Mesh body positioning is consistent, predictable, and reproducible

Quadratic fixation offers a dual mechanism of action (cf. 1)

Indications for Use

The Coloplast Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. The product is contraindicated for the following patients:

It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the possible warnings associated with the use of this product. Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient.

Adverse Reactions

No undesirable effects that could be directly attributed to the polypropylene fibers/materials have been reported in the literature. As with all foreign bodies, the Virtue sling system is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. The resulting response could lead to wound dehiscence, extrusion, erosion, inflammation or fistula formation. The following complications are known to occur with synthetic slings:

Patients should be monitored regularly after the device has been implanted. Known risks of incontinence surgical procedures include extrusion, erosion, infection, sling migration, pain, transient or permanent retention, bladder outlet obstruction, and, continued stress urinary incontinence and persistent or new overactive bladder symptoms. The occurrence of these responses may require operative intervention with removal of part of or the complete sling. No undesirable effects directly attributed to materials used in the introducers have been reported in the literature.

See the device manual for detailed information regarding the implant procedure, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp at1-800-258-3476 and/or consult the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.